I Holland explain how to get more out of tablet tooling
I Holland
The efficient and accurate management of punches and dies is vital to optimise profitability and productivity in modern tablet manufacturing. However, keeping track of tablet tooling is not an easy task and can be a daunting undertaking. There are clear trends within tablet production today; these include the increase of capacity, flexibility, speed of response and robust traceability with the core objective of maximised press uptime. Currently many tablet manufacturers accept that tooling is a consumable item to be written off as part of the costs of the business. Through the development of computer-based monitoring systems this way of thinking is changing and productivity per punch can be maximised more effectively.
Any problems within tool inventory management can have serious implications on the bottom line and manufacturers should have a complete audit trail covering tooling usage and maintenance. This is not only good practice but an important regulatory requirement in the majority of pharmaceutical environments. Without a robust management system that controls the procedure effectively there will certainly be adverse effects.
Tooling management systems – the key to increased tablet production
The costs of tool replacement are often known, however hidden costs such as those created by the unavailability of tools due to avoidable damage or unforeseen replacement can be lacking, and by implementing a management system to monitor all aspects of the tooling being used increases production and reduces downtime and time to market.
Deployment of a tooling management system can significantly improve tooling inventory availability. The data can also provide information to effectively measure areas of performance by way of showing what and how many products have been produced and a summary of any production issues experienced. This can be used in a controlled tiered access system by all personal without specific technical expertise required.
One such management system that helps to combat downtime is I Holland’s Tool Management System (IH-TMS), which allows proactive monitoring of tooling rotations, inventory and maintenance. The software has been specifically developed to maintain efficient, well-organised and in-depth monitoring of tablet production giving manufacturers a complete audit trail on tooling usage and maintenance. It also incorporates an in-depth guide to tooling specification and troubleshooting so any problems flagged up can be traced and rectified. In addition, it has the capability to archive tablet and tool images and drawings and incorporates an alarm to alert users of any problems including over compression, when maintenance is required and even when tooling replacements should be planned.
Within pharmaceutical manufacturing the importance of knowing where tools are, and what condition they are in, should be a priority. Without this information, either unnecessary tooling replacements are made, reducing productivity, or punches are deployed when they should be in maintenance or replaced. The latter scenario breeds problems with the end tablet when it is found that the tooling being used does not meet the highly demanding process of tablet manufacture. Rejected tablets, wasted formulation and press downtime is the usual result. In addition to this, not having a clear picture of tooling availability may lead to the loss of opportunities in a fast moving competitive environment.
Implementing a tooling management system like IH-TMS will fulfil the core requirement of enabling tablet manufacturers to manage their tooling in an ordered, traceable way, with minimal technical expertise required to use the system. Not only is it easy to use and allows all of the production team to monitor outcomes with only simple training involved, it is also extremely affordable demonstrating cost saving through increased tooling productivity and press uptime.
Companies throughout the world are set to benefit from the multilingual and adaptable system, which is available in different configurations to work flexibly and seamlessly within an established manufacturing facility.
Such management systems should also be compliant with protocols like the FDA’s Code of Federal Regulations – 21-CFR part 11, so important electronic records and electronic signatures can be traced.
Why does tablet tooling fail us?
There are many reasons why tooling becomes less effective leading to poor tablet production, one such problem being the impact due to damage and wear caused by abrasive formulations. I Holland has seen the issues created by this common problem resulting in time consuming and costly mistakes for the tablet manufacturer. If the correct procedures are put in place at the beginning of the process and a proven tool management system is implemented, tooling issues should be prevented.
Damage through handling can be another significant production failing. There are several stages of the tablet manufacturing process where damage can take place, including unpacking the tooling, loading/unloading the tools in or out of the tablet press, during tool cleaning/maintenance procedures and storage/transportation. If damage occurs it can lead to the production of poor quality tablets, and even further damage to both the tooling and the tablet press. It is important to understand the delicate nature of the tooling and operate good tool care, maintenance, storage and handling procedures, to keep this problem to a minimum. This should be done through adopting a planned process for tooling maintenace and storage.
A core feature of a system like the IH-TMS system is the ability to keep track of the tooling maintenance; the correct maintenance is critical in obtaining maximum life from punches and dies. In turn this allows the person in charge of managing the tool room to prioritise maintenance activity by creating a work-to list. By implementing an advanced management system, problems like wear to punch heads can be detected before they impact on production. Such a system can monitor the quality of tooling and processes that are already being used like the I Holland PharmaCare 7 Step Process, a logical, professional approach to tooling maintenance and storage which has already been adopted by many companies around the world as a Standard Operating Procedure (S.O.P). Implementing a planned professional process like the ‘7 Steps’ is key to getting the best from tooling.
Auditing-helping to trace poor maintenance procedures
By auditing tooling and tooling procedures, poor handling and maintenance techniques will be flagged up through software like I Holland’s IH-TMS tooling system. A professional tooling and procedure audit is a simple way to directly detect and rectify this, ultimately saving many hours of reduced production through unplanned tooling maintenance and replacements. By combining tooling management software and maintenance procedures as an SOP, uptime can only increase.
Through a site visit by a tooling expert, and a review of tool maintenance procedures, methods and the equipment used, problems can be traced to root cause. Quality tooling manufacturers like I Holland can advise on an informed and working solution, or the optimisation of current maintenance techniques. This helps to save not just money but also time by diagnosing the problem, and offering a solution.
Implementing a simple maintenance process
The use of a maintenance process like I Holland’s PharmaCare 7 Steps will help in maintaining and storing punches and dies correctly to ensure tooling is clean, serviceable and within specification when required for production, resulting in a better product for longer, reducing costs and increasing profitability.
The 7-step process includes:
- Clean: Clean is the most critical part of the process. Punch and die cleaning is essential for the removal of residue and to avoid product contamination and potential production issues such as sticking and picking caused by old product adhering to the surface of the punch tip. This step can be used to highlight damage to punch tip edges and damage that may occur in the form of nicks and bruises causing burrs and occasionally chipping. Approximately 80% of damage to punches and dies is usually caused accidentally when handling the punches through the production and tool care processes.
- Assess: Punches and dies should be visually inspected under magnification for signs of damage, wear or corrosion, and to validate the cleaning process to establish how the production process is running.
- Repair: Light surface wear, corrosion and damage on tooling can be repaired and polished to a useable condition. Damaged tips can result in poor quality tablets and inferior embossing definition. Equipment such as a motorized chuck and double ended polishing motor are used in conjunction with abrasive polishing accessories.
- Measure: Measuring is essential after repair to ensure that critical tooling dimensions have been maintained within an acceptable working tolerance. Measuring should be carried out at regular intervals even if repair has not been necessary, to check for natural wear due to the compaction process.
- Polish: Controlled, light polishing on a frequent basis will ensure the tools are maintained to a smooth finish, helping to maximise tooling life and reduce problems such as sticking and capping.
- Lubricate: Lubrication is important to protect, preserve and aid smooth operation of the tooling.
- Store: Tooling storage and transportation to the production area should be specifically designed to maximise security and safe handling to minimise damage and deterioration.
Application of the 7 Step Process will have a direct impact on the reduction of many common tablet and tooling problems, resulting in a better quality tablet, and can provide direct cost saving. A process like this should be monitored through a system such as the I Holland IH-TMS.
Correct maintenance is critical in obtaining maximum life from punches and dies. A high percentage of punch and die problems can be conclusively traced back to poor handling and maintenance procedures. With the use of a monitoring system, which can record data in real-time and offer instant solutions, together with the application of a structured maintenance process, the direct impact on the reduction of many common tablet and tooling problems, results in a better quality end product.
Adopting these recommended ‘best practices’ will have direct cost savings to the tablet manufacturer as the maximum life from tablet tooling is extended and production is increased.